The objective of this study is to compare the effect on mean maternal and neonatal pH, and 24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated versus normal saline in caesarean section at Mulago Hospital. The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than intraoperative infusion of normal saline.
Fluid therapy in caesarean section surgery in Mulago Hospital is done mostly with 0.9% normal saline (NS). Several studies have highlighted the complications associated with large infusion of normal saline. Few studies have compared the effects of an alternative crystalloid, Ringer's Lactate (RL), on perinatal pH and postoperative morbidity in caesarean section surgery. This trial will be performed in Mulago Hospital Labour Ward theatre on parturients who consent and are scheduled for either elective or emergency caesarean section under spinal anaesthesia from September 2011 to May 2012. Study fluid will be administered intraoperatively only. Preoperative and postoperative venous blood samples will be drawn for venous blood gases, serum urea and creatinine. Placental umbilical arterial cord blood will also be drawn for neonatal arterial blood gases. Mothers will be followed up for 24 hours for incidence of postoperative morbidity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Crystalloid fluid
Crystalloid fluid
Mulago Hospital Labour Suite Operating Theatre
Kampala, Uganda
Change in Maternal pH from preoperative baseline
The aim is to study the effect of the study fluid on maternal pH. pH will be measured preoperatively and immediately postoperatively before the patient leaves the recovery room.
Time frame: Intraoperatively
Neonatal pH
A sample of umbilical arterial cord blood will be drawn after ligating the cord to measure neonatal pH
Time frame: Within 30 seconds of umbilical cord ligature
Change in maternal base excess from preoperative baseline
The aim is to study the effect of the study fluid on maternal base excess. Base excess will be measured preoperatively and immediately postoperatively before the patient leaves the recovery room.
Time frame: Intraoperatively
Number of mothers with postoperative morbidity events
Using a Post-Operative Morbidity Survey (POMS) mothers will be followed up postoperatively for 24 hours assessing incidence of morbidity in the following systems: Pulmonary, Renal, Gastrointestinal, Cardiovascular, Neurological, and Hematological.
Time frame: 24 hours postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.